Peutz-Jeghers SyndromeNCT06242457
Poorly Differentiated Adenocarcinoma of the Jejunum in a Patient With Peutz-Jeghers Syndrome: A Case Report
An observational study of Peutz-Jeghers Syndrome, run by Haramaya Unversity at 1 site in Ethiopia.
Trial summary
Our study is a case report of one of the rarest risk factor, Peutz-Jeghers syndrome, of small bowel malignancy detected in a patient with poorly differentiated adenocarcinoma of small bowel(jejunum) Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Peutz-Jeghers Syndrome
- How many people
- 1 participants
- Where
- 1 siteEthiopia
- Study dates
- 15 Jul 2023to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: New patient came to emergency department as routine activity.
Who may be able to join
- not necessary
Who cannot join
- not necessary
Trial locations and contacts
1 site in 1 country.
About this study
Our study is a case report of one of the rarest risk factor, Peutz-Jeghers syndrome, of small bowel malignancy detected in a patient with poorly differentiated adenocarcinoma of small bowel(jejunum)
Read the detailed description
Case presentation: A 25-year-old male patient presented to the emergency department with generalized peritonitis caused by a perforated jejunal mass. The patient underwent an emergency exploratory laparotomy. There was 800 ml of thin pus in the peritoneal cavity and 5 cm by 6 cm perforated mass over the jejunum, 30cm from the ligament of the treitz, which extends to the mesentery. Palpable jejunal mesenteric lymphadenopathies were found. There were palpable intraluminal polyps with an inverted serosal surface for some of them, which were identified as 10cm proximal and 20cm distal to the mass. The pus was sucked out, and the mass was resected with its mesenteric lymph nodes and segments containing polyps, a total of 40cm of jejunum. Subsequently, end-to-end hand-sewn anastomosis was performed, and the abdomen was closed. The histopathology report showed poorly differentiated adenocarcinoma, stage IIIC (PT3, PN2), and Peutz-Jeghers polyps, suggesting Peutz-Jeghers syndrome. Lympho-vascular invasion was also noted. The tumor has affected seven of the 12 lymph nodes that have been identified. After 6weeks of uneventful follow-up at the surgical referral clinic, the patient was referred to the oncology department for adjuvant chemotherapy.
- Conditions
- Peutz-Jeghers Syndrome
- Medical subject headings
- Peutz-Jeghers Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete resection of adenocarcinomas located in the jejunum or ileum is associated with 5-year survival rates of 20% to 30%.
Even though small bowel malignancy is a rare entity, early detection is a challenging issue, especially when it happens below the ligaments of the trietz. Peutz-Jeghers syndrome was a potential risk factor in our case.
Measured: 5months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start15 Jul 2023
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peutz-Jeghers SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haramaya Unversity
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fufa Miresa, Haramaya Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242457
- Sponsor's protocol ID
- HU
- Status last verified
- Feb 2024
- First submitted
- 29 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Poorly Differentiated Adenocarcinoma of the Jejunum in a Patient With Peutz-Jeghers Syndrome: A Case Report
- ClinicalTrials.gov ID
- NCT06242457
- Acronym / sponsor ID
- HU
- Conditions
- Peutz-Jeghers Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Haramaya UnversityUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our study is a case report of one of the rarest risk factor, Peutz-Jeghers syndrome, of small bowel malignancy detected in a patient with poorly differentiated adenocarcinoma of small bowel(jejunum)
Detailed description
Case presentation: A 25-year-old male patient presented to the emergency department with generalized peritonitis caused by a perforated jejunal mass. The patient underwent an emergency exploratory laparotomy. There was 800 ml of thin pus in the peritoneal cavity and 5 cm by 6 cm perforated mass over the jejunum, 30cm from the ligament of the treitz, which extends to the mesentery. Palpable jejunal mesenteric lymphadenopathies were found. There were palpable intraluminal polyps with an inverted serosal surface for some of them, which were identified as 10cm proximal and 20cm distal to the mass. The pus was sucked out, and the mass was resected with its mesenteric lymph nodes and segments containing polyps, a total of 40cm of jejunum. Subsequently, end-to-end hand-sewn anastomosis was performed, and the abdomen was closed. The histopathology report showed poorly differentiated adenocarcinoma, stage IIIC (PT3, PN2), and Peutz-Jeghers polyps, suggesting Peutz-Jeghers syndrome. Lympho-vascular invasion was also noted. The tumor has affected seven of the 12 lymph nodes that have been identified. After 6weeks of uneventful follow-up at the surgical referral clinic, the patient was referred to the oncology department for adjuvant chemotherapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- New patient came to emergency department as routine activity.
Key inclusion criteria (1 listed)
- not necessary
Key exclusion criteria (1 listed)
- not necessary
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complete resection of adenocarcinomas located in the jejunum or ileum is associated with 5-year survival rates of 20% to 30%.
Time frame: 5months
Even though small bowel malignancy is a rare entity, early detection is a challenging issue, especially when it happens below the ligaments of the trietz. Peutz-Jeghers syndrome was a potential risk factor in our case.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peutz-Jeghers Syndrome, run by Haramaya Unversity at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete resection of adenocarcinomas located in the jejunum or ileum is associated with 5-year survival rates of 20% to 30%. (time frame: 5months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.